Dataset Information

Cost-Utility Analysis of Non-Contrast Abbreviated Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance in Cirrhosis.

ABSTRACT:

Background/aims

Ultrasonography has a low sensitivity for detecting early-stage hepatocellular carcinoma (HCC) in cirrhotic patients. Non-contrast abbreviated magnetic resonance imaging (aMRI) demonstrated a comparable performance to that of magnetic resonance imaging without the risk of contrast media exposure and at a lower cost than that of full diagnostic MRI. We aimed to investigate the cost-effectiveness of non-contrast aMRI for HCC surveillance in cirrhotic patients, using ultrasonography with alpha-fetoprotein (AFP) as a reference.

Methods

Cost-utility analysis was performed using a Markov model in Thailand and the United States. Incremental cost-effectiveness ratios were calculated using the total costs and quality-adjusted life years (QALYs) gained in each strategy. Surveillance protocols were considered cost-effective based on a willingness-to-pay value of $4,665 (160,000 Thai Baht) in Thailand and $50,000 in the United States.

Results

aMRI was cost-effective in both countries with incremental cost-effectiveness ratios of $3,667/QALY in Thailand and $37,062/QALY in the United States. Patient-level microsimulations showed consistent findings that aMRI was cost-effective in both countries. By probabilistic sensitivity analysis, aMRI was found to be more cost-effective than combined ultrasonography and AFP with a probability of 0.77 in Thailand and 0.98 in the United States. By sensitivity analyses, annual HCC incidence was revealed as the most influential factor affecting cost-effectiveness. The cost-effectiveness of aMRI increased in settings with a higher HCC incidence. At a higher HCC incidence, aMRI would remain cost-effective at a higher aMRI-to-ultrasonography with AFP cost ratio.

Conclusions

Compared to ultrasonography with AFP, non-contrast aMRI is a cost-effective strategy for HCC surveillance and may be useful for such surveillance in cirrhotic patients, especially in those with high HCC risks.

SUBMITTER: Decharatanachart P

PROVIDER: S-EPMC10791494 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

Cost-Utility Analysis of Non-Contrast Abbreviated Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance in Cirrhosis.

Decharatanachart Pakanat P Pan-Ngum Wirichada W Peeraphatdit Thoetchai T Tanpowpong Natthaporn N Tangkijvanich Pisit P Treeprasertsuk Sombat S Rerknimitr Rungsun R Chaiteerakij Roongruedee R

Gut and liver 20230810 1

<h4>Background/aims</h4>Ultrasonography has a low sensitivity for detecting early-stage hepatocellular carcinoma (HCC) in cirrhotic patients. Non-contrast abbreviated magnetic resonance imaging (aMRI) demonstrated a comparable performance to that of magnetic resonance imaging without the risk of contrast media exposure and at a lower cost than that of full diagnostic MRI. We aimed to investigate the cost-effectiveness of non-contrast aMRI for HCC surveillance in cirrhotic patients, using ultraso ...[more]

PMID: 37560799

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Project description:BackgroundGiven the limited capacity and suboptimal sensitivity of ultrasonography (US), gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI) demonstrates good diagnostic performance for hepatocellular carcinoma (HCC). Some researchers have proposed that the abbreviated MRI (AMRI) protocols have potential as a surveillance tool. However, few studies have compared multiple AMRI protocols with complete Gd-EOB-DTPA contrast-enhanced MRI for HCC surveillance. We aimed to explore and compare the diagnostic performance of 3 AMRI protocols as HCC surveillance in high-risk patients.MethodsThis multi-center, retrospective, blinded reader study conducted in China consecutively enrolled 339 patients with hepatitis and/or cirrhosis who underwent complete Gd-EOB-DTPA contrast-enhanced MRI for HCC surveillance from 2020 to 2023. We extracted 3 additional AMRI protocols: noncontrast-AMRI [NC-AMRI: T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI)]; dynamic-AMRI (Dyn-AMRI: early and late arterial phases, portal venous phase, and DWI); and hepatobiliary phase-AMRI (HBP-AMRI: T2WI, DWI, and HBP). Then, 2 independent radiologists assessed the AMRI and complete Gd-EOB-DTPA contrast-enhanced MRI protocols. Patients were classified as HCC positive/HCC negative based on the reference standard. Agreement was assessed using Kappa statistics. The acquisition time differences of the 4 MRI protocols were analyzed by analysis of variance (ANOVA). Per-lesion HCC diagnostic performances were compared by Cochran's Q test. Receiver operating characteristic (ROC) curves for the 3 AMRI protocols were evaluated, and the area under the ROC curve (AUROC) was calculated and compared by DeLong's test.ResultsA total of 353 lesions were detected in the 339 included patients, and 21/339 patients were diagnosed with HCC (prevalence, 6.2%). The inter-observer agreement was good for all 4 MRI protocols (k>0.75). Acquisition times differed significantly (P<0.001), from the shortest to the longest: NC-AMRI (263.44±5.05 s) < HBP-AMRI (269.18±4.93 s) < Dyn-AMRI (307.71±4.93 s) < complete Gd-EOB-DTPA contrast-enhanced MRI (582.03±3.59 s). The sensitivity (Cochran's Q=14.667, P=0.002) and specificity (Cochran's Q=59.682, P<0.001) of 4 MRI protocols were statistically significant. HBP-AMRI showed the highest sensitivity (84.00%), whereas Dyn-AMRI exhibited the highest specificity (99.39%) among 3 AMRI protocols. The per-lesion positive predictive value (PPV) for the NC-AMRI, Dyn-AMRI, and HBP-AMRI was 41.66%, 88.89%, and 47.72%, the corresponding negative predictive value (NPV) was 96.21%, 97.31%, and 98.70%, and the number needed to diagnose (NND) for the NC-AMRI, Dyn-AMRI, HBP-AMRI, and complete Gd-EOB-DTPA contrast-enhanced MRI was: 1.865, 1.577, 1.234, and 1.569, respectively. DeLong's test showed the AUROC value of either Dyn-AMRI or HBP-AMRI was significantly higher than that of NC-AMRI (Z=2.330, P=0.019; Z=2.680, P=0.007, respectively), but no significant difference between HBP-AMRI and Dyn-AMRI (Z=1.643, P=0.100).ConclusionsAMRI protocols can be implemented in clinical practice as a patient-centered and tailored regimen for HCC surveillance in China. NC-AMRI might become an optional tool due to its minimal scanning time, lower cost, and exemption from contrast agents. Dyn-AMRI, achieving the highest specificity, is a reliable surveillance strategy. HBP-AMRI as a favorable alternative showed a high sensitivity and NPV while maintaining considerable specificity and NND.

Project description:Background & aimsReinforced hepatocellular carcinoma (HCC) surveillance using magnetic resonance imaging (MRI) could increase early tumour detection but faces cost-effectiveness issues. In this study, we aimed to evaluate the cost-effectiveness of MRI for the detection of very early HCC (Barcelona Clinic Liver Cancer [BCLC] 0) in patients with an annual HCC risk >3%.MethodsFrench patients with compensated cirrhosis included in 4 multicentre prospective cohorts were considered. A scoring system was constructed to identify patients with an annual risk >3%. Using a Markov model, the economic evaluation estimated the costs and life years (LYs) gained with MRI vs. ultrasound (US) monitoring over a 20-year period. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the incremental costs by the incremental LYs.ResultsAmong 2,513 patients with non-viral causes of cirrhosis (n = 840) and/or cured HCV (n = 1,489)/controlled HBV infection (n = 184), 206 cases of HCC were detected after a 37-month follow-up. When applied to training (n = 1,658) and validation (n = 855) sets, the construction of a scoring system identified 33.4% and 37.5% of patients with an annual HCC risk >3% (3-year C-Indexes 75 and 76, respectively). In patients with a 3% annual risk, the incremental LY gained with MRI was 0.4 for an additional cost of €6,134, resulting in an ICER of €15,447 per LY. Compared to US monitoring, MRI detected 5x more BCLC 0 HCC. The deterministic sensitivity analysis confirmed the impact of HCC incidence. At a willingness to pay of €50,000/LY, MRI screening had a 100% probability of being cost-effective.ConclusionsIn the era of HCV eradication/HBV control, patients with annual HCC risk >3% represent one-third of French patients with cirrhosis. MRI is cost-effective in this population and could favour early HCC detection.Lay summaryThe early identification of hepatocellular carcinoma in patients with cirrhosis is important to improve patient outcomes. Magnetic resonance imaging could increase early tumour detection but is more expensive and less accessible than ultrasound (the standard modality for surveillance). Herein, using a simple score, we identified a subgroup of patients with cirrhosis (accounting for >one-third), who were at increased risk of hepatocellular carcinoma and for whom the increased expense of magnetic resonance imaging would be justified by the potential improvement in outcomes.

Project description:BackgroundUltrasonography (US) is recommended as a standard surveillance tool for patients with a high risk of developing hepatocellular carcinoma (HCC). However, the low sensitivity of US for small HCC can lead to surveillance failure, resulting in advanced stage tumor presentations. For the early detection of HCC in high-risk patients and to improve survival and prognosis, a new efficient imaging tool with a high sensitivity for HCC detection is needed. The purpose of this study is to evaluate and compare the feasibility and efficacy of non-contrast magnetic resonance imaging (MRI) with US as a surveillance tool for HCC in patients with liver cirrhosis.MethodsMAGNUS-HCC is a prospective, multicenter clinical trial with a crossover design for a single arm of patients. This study was approved by six Institutional Review Boards, and informed consent was obtained from all participants. All patients will undergo liver US every 6 months and non-contrast liver MRI every 12 months during a follow-up period of 3 years. If a focal liver lesion suspected of harboring HCC is detected, dynamic liver computed tomography (CT) will be performed to confirm the diagnosis. After the last surveillance round, patients without suspicion of HCC or who are not diagnosed with HCC will be evaluated with a dynamic liver CT to exclude false-negative findings. The primary endpoint is to compare the rate of detection of HCC by US examinations performed at 6-month intervals with that of yearly non-contrast liver MRI studies during a 3-year follow-up. The secondary endpoint is the survival of the patients who developed HCC within the 3-year follow-up period.DiscussionMAGNUS-HCC is the first study to compare the feasibility of non-contrast MRI with US as a surveillance tool for the detection of HCC in high-risk patients. We anticipate that the evidence presented in this study will establish the efficacy of non-contrast MRI as a surveillance tool for HCC in high-risk patients.Trial registrationThe date of trial registration ( NCT02551250 ) in this study was September 15, 2015, and follow-up is still ongoing.

Dataset Information

Cost-Utility Analysis of Non-Contrast Abbreviated Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance in Cirrhosis.

Background/aims

Methods

Results

Conclusions

Publications

Cost-Utility Analysis of Non-Contrast Abbreviated Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance in Cirrhosis.

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